The Veterinary Medicines Regulations 2008

1. Introductory Text

2. PART 1 Introduction

   1. 1. Title and commencement

   2. 2. Definition of “veterinary medicinal product”, interpretation and scope

   3. 3. Products to which these Regulations do not apply

3. PART 2 Authorised veterinary medicinal products

   1. 4. Placing a veterinary medicinal product on the market

   2. 5. Manufacture of veterinary medicinal products

   3. 6. The finished product

   4. 7. Classification, supply and possession of the product

   5. 8. Administration of the product

   6. 9. Importation of authorised veterinary medicinal products

   7. 10. Advertising the product

   8. 11. Advertising of prescription products and products containing psychotropic drugs or narcotics

   9. 12. Defence of publication in the course of business

   10. 13. Wholesale dealing

   11. 14. Feedingstuffs

   12. 15. Exemptions

   13. 16. Fees

4. PART 3 Records

   1. 17. Food-producing animals: proof of purchase of veterinary medicinal products

   2. 18. Food-producing animals: records of administration by a veterinary surgeon

   3. 19. Food-producing animals: records of acquisition and administration

   4. 20. Food-producing animals: retention of records

   5. 21. Records by a holder of a manufacturing authorisation

   6. 22. Records by a holder of a wholesale dealer’s authorisation

   7. 23. Records of the receipt or supply of prescription products

   8. 24. Records of products administered to a food-producing animal under the cascade

5. PART 4 Unauthorised veterinary medicinal products

   1. 25. Importation of an unauthorised veterinary medicinal product

   2. 26. Possession of an unauthorised veterinary medicinal product

   3. 27. Supply of an unauthorised veterinary medicinal product

6. PART 5 Miscellaneous provisions, enforcement and offences

   1. 28. The Veterinary Products Committee

   2. 29. Veterinary Products Committee appeals procedure

   3. 30. Appeals to an appointed person

   4. 31. Exports

   5. 32. Time limits

   6. 33. Appointment of inspectors

   7. 34. Powers of entry

   8. 35. Powers of an inspector

   9. 36. Inspection of pharmacies

   10. 37. Obstruction

   11. 38. Improvement notices

   12. 39. Appeals against improvement notices

   13. 40. Powers of a court on appeal

   14. 41. Seizure notices

   15. 42. Publication

   16. 43. Penalties

   17. 44. Northern Ireland

   18. 45. Revocations and consequential amendment

7. Signature

8. 1. SCHEDULE 1

      Marketing authorisations

      1. PART 1 Application for a marketing authorisation

      2. PART 2 Derogations from some of the requirements in Part 1

      3. PART 3 Grant of a marketing authorisation

      4. PART 4 Variations of marketing authorisations on the application of the holder

      5. PART 5 Suspension, etc. of a marketing authorisation

      6. PART 6 Mutual recognition and multiple applications

      7. PART 7 Labelling and package leaflets

      8. PART 8 Pharmacovigilance

      9. PART 9 Homeopathic remedies

   2. SCHEDULE 2

      The manufacture of veterinary medicinal products

      1. PART 1 Manufacturing authorisations

      2. PART 2 Authorisation of manufacturers of autogenous vaccines

      3. PART 3 Authorisation of blood banks

      4. PART 4 Authorisation of manufacturers of products for administration under the cascade

      5. PART 5 Authorisation of equine stem cell centres

   3. SCHEDULE 3

      Classification and supply, wholesale dealers and sheep dip

      1. PART 1 Classification and supply of authorised veterinary medicinal products

      2. PART 2 Requirements for a wholesale dealer’s authorisation

      3. PART 3 Sheep dip

   4. SCHEDULE 4

      Administration of a veterinary medicinal product outside the terms of a marketing authorisation

   5. SCHEDULE 5

      Medicated feedingstuffs and specified feed additives

   6. SCHEDULE 6

      Exemptions for small pet animals

   7. SCHEDULE 7

      Fees

      1. PART 1 Introduction

      2. PART 2 Fees relating to marketing authorisations

      3. PART 3 Fees payable by manufacturers

      4. PART 4 Fees relating to a wholesale dealer’s authorisation

      5. PART 5 Fees relating to feedingstuffs

      6. PART 6 General

9. Explanatory Note